C
Our infusion pump is classed as a Type CF device because the needle, the applied part goes through the skin and is in direct contact with body fluids. In 60601 edition 3 par 4.6 we are to make an assessment as to whether exposed metal in the case is an applied part. If the patient makes casual contact with this exposed metal it is against his skin and not in direct contact with body fluids so the same low impedance path of the applied part, the needle does not exist.
Should this contact with exposed metal need to have the same 10uA leakage requirement as the needle or is the 100uA touch current limit in 8.7.3 c sufficient?
Should this contact with exposed metal need to have the same 10uA leakage requirement as the needle or is the 100uA touch current limit in 8.7.3 c sufficient?